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Procedure

OPEP Device for Asthma (AeroMUC Trial)

N/A

Waitlist Available

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist)

Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a device can help reduce mucus plugging and improve airway function in people with asthma.

Who is the study for?

Adults with moderate-to-severe asthma, diagnosed over a year ago and meeting specific criteria like an ACQ score above 1.5, certain levels of eosinophils or nitric oxide in their breath, and a CT mucus score over 4. They must be on a stable dose of inhaled corticosteroids and can't have other major lung diseases or recent substance abuse.

What is being tested?

The trial is testing if using the Aerobika OPEP device daily improves mucus clearance and airflow in adults with serious asthma. Participants are randomly chosen to either use the device or not, allowing researchers to compare outcomes between the two groups.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort from using the device such as coughing or throat irritation due to increased mucus movement.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a device or metal in my body that cannot be removed.

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I have had a serious infection needing hospital care or antibiotics in the last month.

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I have smoked the equivalent of 10 packs of cigarettes a year or more and have quit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Computed Tomography (CT) mucus score

Secondary study objectives

Asthma Control Questionnaire-5 (ACQ-5)

Asthma Control Test (ACT)

Asthma Quality of Life Questionnaire (AQLQ)

+15 more

Other study objectives

Mucin proteins in sputum

Sputum rheology

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Aerobika OPEP deviceActive Control1 Intervention

The OPEP system (Aerobika®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. OPEP therapy (Aerobika ®) enforces resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucus. Participants will take home the device and use it twice daily for 16 weeks.

Group II: Standard of careActive Control1 Intervention

Standard of care management for 16 weeks.

0 / 3Eligibility criteria met